Trial reportPloS one2024
Randomized controlled trial of an Internet-of-Medical-Things device for patient-guided anorectal biofeedback therapy.
Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- A Digital Therapeutic Pelvic Health System Improves Fecal Incontinence Symptoms in a Real-World Patient Cohort.Diseases of the colon and rectum · 2026Observational
- A Global Scoping Review of Clinicians' Perceptions of Anorectal Biofeedback Compared with Novel Australian Data.Journal of clinical medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Biofeedback therapy is useful for treatment of functional defecation disorders but is not widely available and is labor intensive. We developed an Internet-of-Medical-Things (IoMT) device, enabling self-guided biofeedback therapy. This study assesses the safety and efficacy of self-guided biofeedback therapy using the IoMT device in comparison to standard operator-led therapy. Patients experiencing urge or seepage fecal incontinence (≥1 episode/week) were randomly assigned to either our IoMT system or to the conventional anorectal manometry-based therapy. Both interventions comprised six weekly sessions, focusing on enhancing anal strength, endurance, and coordination. The novel device facilitated self-guided therapy via visual instructions on a companion app. Primary outcomes included safety/tolerability, changes in Vaizey severity scores, and alterations in anorectal pressure profiles. Twenty-five patients (22 females, 3 males) participated, with 13 in the novel device group and 12 in the standard therapy group. Both groups showed significant reductions in symptom severity scores: IoMT device group -4.2 (95% CI: -4.06, -4.34, p = 0.018), and the standard therapy group -4.8 (95% CI: -4.31, -5.29, p = 0.028). Anal sphincter resting pressure and sustained squeeze time improved significantly in both groups, and the novel device group demonstrated an increase in maximum sphincter squeeze pressure. There were no significant differences between the therapy groups. Importantly, the experimental device was well-tolerated compared with standard therapy, with no serious adverse events observed. This study demonstrates the comparable efficacy of self-administered biofeedback using the IoMT device with traditional biofeedback therapy. The results demonstrates the potential of the IoMT device as a safe, self-guided method for FI therapy, offering convenience and effectiveness in fecal incontinence management.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.